1. Field of the Invention
The present invention relates to methods and various compositions and formulations for treating and preventing diabetes and its associated symptoms and conditions. Specifically, the present invention relates to Morinda citrifolia-based methods and naturaceutical formulations for treating pre-existing diabetes conditions, as well as to Morinda citrifolia-based methods and naturaceutical formulations for inhibiting, reducing, or preventing the onset or reducing the onset potential of future or additional diabetic developments. The present invention is suited for treatment and prevention of diabetes as commonly experienced in mammals, and particularly humans.
2. Background of the Invention and Related Art
Diabetes mellitus (diabetes) is a complex chronic disease which affects a large number of people in the United States. More specifically, diabetes mellitus is a group of diseases characterized by high levels of blood glucose resulting from defects in insulin secretion, insulin action, or both. It is characterized as a progressive breakdown in normal insulin-related usage of glucose. In order to function properly, the body's use of glucose must comprise a balanced output of insulin from the pancreas to transport glucose effectively to other organs and tissues for storage. Any insulin imbalance or loss of sensitivity can cause a chronic overabundance of glucose leading to diabetes.
It is estimated that a total of 15.7 million people in the United States, approximately 5.9% of the population, have diabetes in one form or another. Of those, 10.3 million people have actually been diagnosed with diabetes, while the other speculated additional 5.4 million people have gone undiagnosed.
Diabetes can be associated with serious complications and premature death. Studies have found that death rates can be twice as high among middle aged people with diabetes as opposed to those who are not suffering from the disease. Moreover, in 1996 diabetes contributed to over 193,000 deaths and was the seventh leading cause of death listed on U.S. death certificates in that same year. This is an alarming statistic considering that diabetes is believed to be under reported both as a condition and as a cause of death.
Diabetes is particularly prevalent among adults. Approximately 6.3 million people over the age of 65 (18.4% of all people in that age group) have diabetes. It is estimated that 8.2% of all adults over the age of 20 have diabetes. A smaller percentage, but nevertheless a significant number of children under the age of 20 in the United States have diabetes (0.16%).
Diabetes is equally likely to strike men as women. However, certain racial and ethnic groups are more likely to be susceptible to diabetes. For example, Mexican Americans are nearly twice as likely to have diabetes as non-Hispanic whites of a similar age as are Hispanics/Latino Americans. American Indians and Alaskan Natives are nearly three times as likely to be diagnosed with diabetes as non-Hispanic whites. Some Asian American also show an increased risk for diabetes. In some circumstances these minority groups are less likely to have access to treatments to help prevent the serious conditions that can arise as a result of diabetes because of their lack of access to health care and prescription medicines.
It is estimated that about 798,000 Americans will be diagnosed with diabetes this year alone. The estimated cost of treatment totals 98 million annually in the US. This problem is compounded by the fact that adult-onset diabetes is increasing at an alarming rate and also striking at younger ages. According to CDC statistics, in 1990–1998 diabetes increased by 33% with a 76% increase among 30–39 years old. Type II diabetes (discussed below) rarely struck before age 40 years of age or older. However, this type of diabetes is showing up in young adults and even children. The disease often causes permanent damage to younger victims before they are diagnosed.
There are several types of diabetes. Diabetes Type I develops in young children and is usually caused by the body's inability to produce insulin. Type I diabetes was previously called insulin-dependent diabetes mellitus (IDDM) or juvenile-onset diabetes. According to the CDC, Type I diabetes may account for 5% to 10% of all diagnosed cases of diabetes. Risk factors are less well defined for Type I diabetes than for type 2 diabetes, but autoimmune, genetic, and environmental factors are involved in the development of this type of diabetes
Diabetes Type II develops later in life, usually as organs & tissues lose their ability to respond effectively to insulin. Type II diabetes was previously called non-insulin dependent diabetes mellitus (NIDDM) or adult-onset diabetes. The CDC estimates Type II diabetes may account for about 90% to 95% of all diagnosed cases of diabetes. Risk factors for Type II diabetes include older age, obesity, family history of diabetes, prior history of gestational diabetes, impaired glucose tolerance, physical inactivity, and race/ethnicity. As was mentioned above, African Americans, Hispanic/Latino Americans, American Indians, and some Asian Americans and Pacific Islanders are at particularly high risk for Type II diabetes.
Gestational diabetes is a third type of diabetes that develops in small but significant percentage of all pregnancies and usually ends with the pregnancy. A small percentage of diabetes may also result from specific genetic syndromes, surgery, drugs, malnutrition, infections, and other illnesses.
The chronic overabundance of glucose associated with this condition damages the body's blood vessels and leads to breakdown of body organs and ultimately death. Either form of diabetes is a disease with serious and deleterious health consequences. If left untreated diabetes can cause retinal degeneration and blindness, kidney and nerve damage, and can contribute to atherosclerosis. In extreme cases diabetes can result in the amputation of limbs and death.
The harmful consequences are not just possibilities but painful realities form many Americans who do not get the treatments they need in time. Again, according to CDC, 12,000–24,000 Americans lose their sight to diabetes each year and approximately 27,900 have kidney failure associated with the condition. Over 55,000 diabetic related amputations are performed each year. Diabetics are two to four times likely to suffer from heart disease, two to four times more likely to have a stroke, and three times more likely to die of complications of flu and pneumonia than non-diabetics.
Other conditions related to diabetes reported by the CDC include: nervous system diseases, which often includes impaired sensation or pain in the feet or hands, slowed digestion of food in the stomach, carpal tunnel syndrome, and other nerve problems, periodontal disease, which is a type of gum disease that can lead to tooth loss, complications of pregnancy, including congenital malformations and death of the fetus, and other complications such as diabetic ketoacidosis and hyperosmolar nonketotic coma.
Medical professionals apply three strategies for treating diabetes. First, reduce glucose absorption, which can be accomplished through with a disciplined diet. Second, reduce glucose synthesis in the liver. Third, accelerate glucose metabolism. Ideally, the most effective treatment will be able to utilize all of the treatments of type I diabetes. However, lack of insulin production by the pancreas makes Type I diabetes particularly difficult to control. Treatment requires a strict regimen that typically includes a carefully calculated diet, planned physical activity, home blood glucose testing several times a day, and multiple daily insulin injections.
Pharmaceuticals play a major role in the treatment of diabetes. Medications, such as Glycosidase inhibitors (Glucobai), Amylase, Glibenclamide, and Niacinamide are effective control drugs. Treatment of Type 1 diabetes functions to maintain blood glucose at near normal levels, and may require home blood glucose testing and multiple daily insulin injections. Treatment of Type 2 diabetes typically may include diet modification and home blood glucose testing, as well as oral medication. Unfortunately, the side effects of these drugs can be unpleasant and distressing. Side effects include hypoglycemia, upset stomach, skin rash or itching, weight gain, kidney problems, fatigue, dizzy spells, gloating and diarrhea.
Accordingly, it would be advantageous to provide a safe, over-the-counter formulation to treat diabetes and to augment or to even replace existing treatments and formulations for diabetes.